Establishing an etiological role of the gut microbiome in the antiphospholipid syndrome phenotype

Completed

• Conditions: antiphospholipid syndrome; 10064477; 10003816; 10000211

• Registration Number: NL-OMON55745
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the
revised Sapporo classification criteria for antiphospholipid syndrome:

At least one of the clinical and at least one of the laboratory criteria below

Clinical criteria

1. Thrombosis
One or more clinical episodes of arterial, venous, or small vessel thrombosis,
in any tissue or organ. Thrombosis must be confirmed by objective validated
criteria (i.e., unequivocal findings of appropriate imaging studies or
histopathology).

2. Pregnancy morbidity
(a) One or more unexplained deaths of a morphologically normal fetus at or
beyond the 10th week of gestation, with normal fetal morphology documented by
ultrasound or by direct examination of the fetus, or
(b) One or more premature births of a morphologically normal neonate before the
34th week of gestation because of: (i) eclampsia or severe pre-eclampsia de*ned
according to standard de*nitions, or (ii) recognized features of placental
insu*ciency*,or
(c) Three or more unexplained consecutive spontaneous abortions before the 10th
week of gestation, with maternal anatomic or hormonal abnormalities and
paternal and maternal chromosomal causes excluded.

Laboratory criteria

a Lupus anticoagulant (LA) present in plasma, on two or more occasions at least
12 weeks apart, detected according to the guidelines of the International
Society on Thrombosis and Haemostasis (Scienti*c Subcommittee on
LAs/phospholipid-dependent antibodies).

b. Anticardiolipin (aCL) antibody of IgG and/or IgM isotype in serum or plasma,
present in medium or high titer (i.e. >40 GPL or MPL, or >the 99th percentile),
on two or more occasions, at least 12 weeks apart, measured by a standardized
ELISA.

c. Anti-b2glycoprotein-I antibody of IgG and/or IgM isotype in serum or plasma
(in titer >the 99th percentile), present on two or more occasions, at least 12
weeks apart, measured by a standardized ELISA, according to recommended
procedures.

Exclusion Criteria

- Age below 18 years
- Current use of antibiotics
- History of gastro-enteritis in the past month
- History of inflammatory bowel disease
- Current use of a vitamine K antagonist
- Planned change in the following medication during the study period (either
start, stop or dose change): platelet aggregation inhibitors, oral
anticoagulants, heparins, hormonal therapy.
- Current pregnancy or pregnancy in the past 6 weeks
- Arterial or venous thrombosis in the past month
- Allergy to vancomycin

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome is the composite of a broad panel of APS<br /><br>pathophysiology-related blood biomarkers. These biomarkers are regarded to<br /><br>collectively reflect the APS phenotype.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> The secondary outcome is gut permeability as measured by lactulose/mannitol<br /><br>test.</p><br>